May be administered as a slow IV push over 2-5 minutes or as an IV infusion over at least 15 minutes in NDD-CKD and HDD-CKD patients

Stable for 7 days

Syringe stability: When diluted with 0.9% NaCI at concentrations raging from 2 mg to 10 mg of elemental
iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe was found to be physically
and chemmically stable for 7 days at controlled room temperature (25oC ± 2oC) and under refrigeration (4oC ± 2oC).

Intravenous admixture stability: When added to intravenous infusion bags (PVC or non-PVC) containing 0.9%
NaCI at concentrations raging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically
stable for 7 days at controlled room temperature (25oC ± 2oC).

CONTRAINDICATIONS
Venofer® is contraindicated in patients with known hypersensitivity to Venofer.

WARNINGS AND PRECAUTIONSSerious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal,
have been reported in patients receiving Venofer. Patients may present with shock, clinically significant hypotension, loss of
consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer
immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer administration for at least
30 minutes and until clinically stable following completion of the infusion. Only administer Venofer when personnel and
therapies are immediately available for the treatment of serious hypersensitivity reactions.
Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion.

Venofer may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer.
Hypotension following administration of Venofer may be related to rate of administration and/or total dose delivered.

Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis.
All adult and pediatric patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit,
serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload. Transferrin saturation (TSAT)
values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing.

Because adverse reactions from post-marketing experience are reported voluntarily from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure. In addition to potential serious hypersensitivity reactions, the following adverse
reactions have been identified during post-approval use of Venofer® (iron sucrose injection, USP): bronchospasm, dyspnea, convulsions, light-headedness, confusion,
angioedema, swelling of the joints, hyperhidrosis, bradycardia and chromaturia.

Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia,
abdominal and muscle pain, edema and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection.
Reactions have occurred following the first dose or subsequent doses of Venofer. Slowing the infusion rate may alleviate symptoms.

Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.

PP-VE-US-0001 10/2016

To report adverse events, please contact American Regent at 1-800-734-9236.
You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.